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WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALChoose a method by clicking on the corresponding radio button on the Report page.New York Laboratories and Blood Banks Able to Segregate Income:RELEASE 1.3 Enter the value of all revenue earned from testing of specimens (regardless of origin) during thepreceding calendar year. Do not report amounts collected and paid to New York State directly byyour facility as part of the New York State Health Care Reform Act - Health Services Surcharge. Enter the amount paid to reference laboratories for tests that are referred. Click Calculate. The Comment section is optional and may be used to provide clarifying information related to thereporting of GAR. Clear button is to clear your entry if you have not clicked on save button. Click Save, if you want to save your entry and complete submission later. If you have already saved and want to re-enter the values again, click on the Reset button. Read the Attestation, click the check box to acknowledge the attestation, then click Submit. The laboratory or blood bank may also opt to request for the GAR information to remain confidential.Click on the check box corresponding to the Confidentiality before clicking Submit.PAGE 10 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALNew York Laboratories and Blood Banks Unable to Segregate Income - Article 28Facility Refer to the Instructions page for a description of entities eligible to report in this manner. Enter the value of the total annual cost of the laboratory. For the purpose of this calculation,Total Annual Laboratory Cost means the total cost, both direct and indirect, salary and non-salarycosts incurred in providing laboratory services for patient care on an annual basis. This totalexcludes the purchase of blood. Enter the Gross Revenue of the Article 28 facility. This is the total annual patient servicesrevenues less contractual adjustments, administrative write-offs, allowances, bad debt, charitycare, etc., in the providing of patient care services (Net Patient Service Revenue). RELEASE 1.3Institutional Cost Report location: Cost Allocation - Ancillary Service Costs; AHA AncillaryCost Allocation, Column, LABORATORY 106 Class 1155.Institutional Cost Report location: Summary - All Services, Exhibit 46; ICR Line Code 300,Column: Sum of All Columns Total Services, Class 00036.Enter the Operating Cost of the Article 28 facility. This is the total annual costs of providingpatient services for the entire facility, including capital costs, but not to include non-patient relatedservices areas, i.e., private physician's offices, or the non-reimbursable costs recognized by thirdparty payers.PAGE 11 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUAL RELEASE 1.3Institutional Cost Report location: Reclassification and Adjustment of Trial BalanceExpenses; Exhibit 11; CMS Line Code 118; Column Reclassified Trial Balance 5, Class20030. Click Calculate Subtotal. Enter the amount paid to reference laboratories for tests that are referred. Click Calculate Total. The Comment section is optional and may be used to provide clarifying information related to thereporting of GAR. Clear button is to clear your entry if you have not clicked on save button. Click Save, if you want to save your entry and complete submission later. If you have already saved and want to re-enter the values again, click on the Reset button. Read the Attestation, click the check box to acknowledge the attestation, then click Submit. The laboratory or blood bank may also opt to request for the GAR information to remain confidential.Click on the check box corresponding to the Confidentiality before clicking Submit.PAGE 12 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALNew York Laboratories and Blood Banks Unable to Segregate Income – All Others GAR must be calculated as if the laboratory or blood bank had billed the client at the prevailingMedicaid rate for their services. The prevailing rate means the fee schedule for clinical laboratoryservices as provided at index.aspx.RELEASE 1.3 A worksheet is provided in the GAR Reporting Module to assist in the calculation. Enter the final estimated GAR value from the worksheet (or custom worksheet). The Comment section is optional and may be used to provide clarifying information related to thereporting of GAR. Clear button is to clear your entry if you have not clicked on save button. Click Save, if you want to save your entry and complete submission later. If you have already saved and want to re-enter the values again, click on the Reset button. Read the Attestation, click the check box to acknowledge the attestation, then click Submit. The laboratory or blood bank may also opt to request for the GAR information to remain confidential.Click on the check box corresponding to the Confidentiality before clicking Submit.PAGE 13 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALLaboratories and Blood Banks not located in New York:RELEASE 1.3 Enter the value of all revenue earned from testing of specimens received from New York stateduring the preceding calendar year Enter the amount paid to reference laboratories for tests that are referred. Click Calculate. Click Save, if you want to save your entry and complete submission later. Clear button is to clear your entry if you have not clicked on save button. If you have already saved and want to re-enter the values again, click on the Reset button. The Comment section is optional and may be used to provide clarifying information related to thereporting of GAR. Read the Attestation, click the check box to acknowledge the attestation, then click Submit. The laboratory or blood bank may also opt to request for the GAR information to remain confidential.Click on the check box corresponding to the Confidentiality before clicking Submit.PAGE 14 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALConsolidating the Reporting of GAR under a Single Facility:When one or more laboratories share a common owner, as evidenced by the sharing of a commonfederal employer identification number (EIN) or the same direct owner name and address as disclosed inthe laboratories most recent List of Owners submitted as part of the annual permit reapplication, theGross Annual Receipts for all those laboratories may be reported under a single laboratory. Directownership means the possession of stock, equity in the capital, or any interest in the profits of the clinicallaboratory. In these instances, the consolidated GAR amount will be reported under one laboratory and allother associated laboratories will report a 0 GAR. These associated laboratories must then enter the PFIof the laboratory that is reporting the consolidated GAR. All laboratories are still required to submit a GARreport.Once consolidation of GAR is approved, all inspection and reference fee invoices and related financialcorrespondence will be combined and sent to the reporting PFI. This will not affect any othercommunication from the Clinical Laboratory Evaluation Program.Reporting 0 GAR:A laboratory may only report a 0 GAR when either: they did not test any specimens in the preceding calendar year; or the laboratory's GAR is included under the report of another laboratory.If choosing option 2, the laboratory must disclose the permanent facility identifier (PFI) of the otherlaboratory. Note that only laboratories that share a common owner can consolidate GAR reporting undera single PFI. Please see the section titled Consolidating the Reporting of GAR under a Single Facilityabove. After entering 0 in the ‘Gross Revenue earned for testing specimens’ field, click Calculate.You MUST enter “0” in the date field, the system does not recognize the defaultplaceholder displayed. The ‘reportable Gross Annual Receipts’ field will populate and new text and data fields willappear: If no specimens were tested in the prior calendar year, click the checkbox next to the text “Did nottest any specimens in ”. If Gross Annual receipts are consolidated under another laboratory’s report that is under commonownership, then enter the PFI of the other laboratory in the field after “Gross Annual Receipts for(year) are reported under PFI number:”.*NOTE: Reporting 0 GAR is not acceptable for not-for-profit entities. If no monies are collected fortesting, then the GAR Report must be estimated based on the Medicaid Prevailing Rate(s) for the testingperformed. For all other situations, you must contact CLEP at clep@health.ny.gov for guidance.RELEASE 1.3PAGE 15 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALVerifying your submission:To verify that the system recorded your submission, click on Submission on the left. If the submissionwas successful the date and time of submission will be displayed. If the submitter is the director orassistant director at facility, the submitter username will be displayed.Past Reports:In 2019 and beyond, laboratories and blood banks will be able to view and print previous GAR Reportingsubmissions. This page only displays GAR Reports that have accepted by the department. Data fromprevious years that were submitted on hard copy forms will not be available in the online GAR ReportingModule.RELEASE 1.3PAGE 16 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALRequesting an Extension for GAR Reporting On the Gross Annual Receipts Reporting Home page, there is a link that points to theExtension Request Date page on the left panel that will take you to the Tools tab.From the Tools tab in eCLEP, click on the Extension Date Request link on the left panel. Select the request type (GAR) from the drop-down menu, Extension Request for. Enter a proposed date for the extension date in the New Date field:RELEASE 1.3PAGE 17 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUAL Use the Reason field to add any notes if deemed necessary.oRequests for extensions beyond May 31st must include a Reason or therequest will be rejected. Clicking the Save button, completes the request process for an extension date. No extra step isrequired.Re-opening the GAR Reporting ModuleTo re-open the GAR reporting module, E-mail:clepreapp@health.ny.govPlease indicate “Re-Open GAR” with your PFI number in the subject line!HCS TimeoutFor security reasons, there are session timeouts after one hour of inactivity and HCS timeouts after eighthours of total connectivity. These timeouts occur without warning. Timeouts take you back to the loginpage and force you to re-enter your User ID and Password. If a timeout occurs before you hit Save on adata entry page, you will lose all your data entry.Exiting eCLEPThere are two ways to exit eCLEP:1. Close your browser by selecting File and Close from the browser's menu.2. Click Logout at the top right.a. The You are now logged off message page displays.RELEASE 1.3PAGE 18 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALTechnical SupportTechnical Support is available for eCLEP and for the NYSDOH Health Commerce System (HCS) in thefollowing areas:Help with HCS Enrollment, HCS Accounts, HCS accessFor additional assistance contact the Commerce Account Management Unit (CAMU) Help Desk:(866) 529-1890 (Mon-Fri 8am – 4:45pm EST/EDT)camu@health.ny.govHelp with eCLEPFor additional assistance contact the Clinical Laboratory Evaluation Program: RELEASE 1.3E-mail support at CLEP@health.ny.gov.PAGE 19 OF 20APRIL 2022

WADSWORTH CENTERCLINICAL LABORATORY EVALUATION PROGRAMECLEP MANUALGlossaryCLEP – Clinical Laboratory Evaluation ProgramDelegated Submitter – a person who has been given written authorization by the Laboratory Director toelectronically submit facility information on behalf of the Director. A Delegated Submitter will be authorizedto enter and submit data electronically using the eCLEP system.DOH – Department of HealtheCLEP – Electronic Clinical Laboratory Evaluation Program application located on the HCSHCS – Health Commerce System – the Department of Health’s secure Internet network that provides datainterchange between health care providers and the NYSDOH.HCS Coordinator – An individual at the laboratory, designated by the laboratory director, who has theresponsibility of requesting additional HCS accounts for data entry individuals. The HCS Coordinator alsoaffiliates HCS User IDs with the laboratory for new users and removes the affiliations for users who haveleft the laboratory.Laboratory Director – an individual who is responsible for the administration of the technical and scientificoperation of a clinical laboratory or blood bank, including the supervision of procedures, reporting of resultsand responsibilities specified in Subpart 19.3 of 10 NYCRR and Article 5 Title V Section 571 of the PublicHealth Law. Such person shall possess a Certificate of Qualification issued pursuant to Part 19 of 10NYCRR. A Director will be authorized to enter, submit and attest to information entered using the eCLEPsystem.NYCRR – New York Codes, Rules and RegulationsNYSDOH – New York State Department of HealthPDF – Portable Document Format file – a file format which creates documents with a consistent look. ThePDF file format was created by Adobe Systems. Adobe Reader software may be downloaded free-ofcharge from: http://www.adobe.com.PFI – Permanent Facility Identifier that identifies a laboratoryUser ID – An identification for logging on to the HCSRELEASE 1.3PAGE 20 OF 20APRIL 2022

GAR home page. Gross Annual Revenue for the previous calendar year is required to be submitted by May 15 of the current year. Requests for extensions may be made via email to clep@health.ny.gov with a subject line including the laboratory PFI and the words "GAR Extension", and the